Regulatory Data Technical Advisor

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🕒 Maio 19

🏛️ District of Columbia, Washington – Remoto

🏛️ District of Columbia – Remote ☕ Washington – Remote

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BryceTech

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2003

🏛️ Governo

🚀 Aeroespacial

Government • Defense • Aerospace

A BryceTech é uma empresa de análises e engenharia que faz parceria com clientes de ciência e tecnologia, oferecendo suporte a programas governamentais e serviços de consultoria empresarial. A empresa oferece uma gama de serviços, incluindo engenharia de sistemas, análise de dados, gestão de programas, gestão de portfólio de tecnologia e cibersegurança. A BryceTech é particularmente notada por sua expertise na economia espacial, segurança nacional, defesa e setores de saúde pública. A empresa também aconselha sobre investimentos em pesquisa e desenvolvimento e apoia a transferência de tecnologia. A BryceTech atende tanto clientes governamentais quanto comerciais, utilizando modelos baseados em pesquisas proprietárias para fornecer insights estratégicos e inteligência competitiva.

Descrição

• Serve as technical SME for CDISC SEND and SENDIG-AR (2019) • Develop validation criteria, business rules, and quality control procedures for DCC ingestion of SEND datasets • Support design and implementation of DCC data architecture and metadata governance frameworks • Establish data acceptance and rejection criteria aligned with regulatory expectations • Contribute to DCC end user interface testing and acceptance criteria • Assist in developing end user training and implementation plans • Ensure alignment with Animal Rule regulatory requirements (21 CFR 314.600 and 601.90) • Assist other contractors by translating regulatory requirements into operational data standards specifications • Perform quality control of dataset packages • Integrate knowledge of nonclinical study conduct to assure correct dataset output • Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages • Communicate findings to team members and management • Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. SEND] review, study report QC, and other reviews, as required • Adhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC efforts • Learn data audit practices with possibility to assist in remote and/or on-site data audits of BARDA contracted research • Provide technical expertise to individual advanced research and development (ARD) and/or nonclinical project coordination teams (PCTs) • Act as the primary data management contact for BARDA ARD/nonclinical PCTs supporting contracts issued to CHEM, RADNUC, and BIOLOGICAL network contract research laboratories (CROs) • Coordinate with PCTs to determine intended use for data derived from contract(s) and establish data management plans intended to ensure data are fit for purpose • Coordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractors • Develop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timeliness • Advise CRO contractors on data delivery and format requirements • Receive and review raw data from CRO contractors for completeness and quality according to established quality control standards • Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs

🎯 Requisitos

• Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological and/or chemical sciences such as medicine, pharmacy, life science fields (e.g., immunology, molecular biology, biochemistry, microbiology, or similar) • Minimum eight (8) years of relevant industry and/or relevant postdoctoral experience in regulatory data standards and analytics • Direct SEND implementation experience • Client-focused approach to work; Ability to prioritize workload in a hybrid/remote work environment

🏖️ Benefícios

• competitive salary • comprehensive health plan including dental and vision coverage • company-paid life & disability insurance policies • 401(k) plan with company match • educational reimbursement program